In a recent Orbit webinar, I was joined by Dr. Simon Ingate of Axian Consulting to discuss the ever-increasing compliance challenges companies face to stay ahead of their regulatory commitments for risk management. The scrutiny on Pharma & Biotech companies shows no indications of waning — as Simon cited, in the first half of 2021 there have been multiple reports and guidances issued on this topic. With many companies already in a reactive-mode keeping up with global regulatory commitments, we posed a two-prong solution for changing the tide: a purpose-built system and an updated, optimized process.
A validated, GvP compliant system such as Orbit is one part of that solution. Orbit is that purpose-built system that is scalable, sustainable and dynamic. It enables the management of the complexities of global-to-local risk management activities and helps prepare organizations for regulatory scrutiny. In combination with refreshed look at optimizing your business processes, your teams will be well positioned to proactively manage your commitments in systematic way and address or mitigate issues before they become regulatory, or most importantly, patient drug safety problems.
To learn more about our recommendations for implementing an optimized Risk Management platform, see our webinar, The evolution of Risk Management: meeting the new standards for compliance.